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EP3784201B1 - Dispositif à tube transnasal pour accéder à une cavité corporelle d'un patient - Google Patents

Dispositif à tube transnasal pour accéder à une cavité corporelle d'un patient

Info

Publication number
EP3784201B1
EP3784201B1 EP19716862.8A EP19716862A EP3784201B1 EP 3784201 B1 EP3784201 B1 EP 3784201B1 EP 19716862 A EP19716862 A EP 19716862A EP 3784201 B1 EP3784201 B1 EP 3784201B1
Authority
EP
European Patent Office
Prior art keywords
tube
inflatable chamber
transnasal
esophagus
patient
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP19716862.8A
Other languages
German (de)
English (en)
Other versions
EP3784201A1 (fr
Inventor
Barbara AMON
Virginie Cuadrado
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP3784201A1 publication Critical patent/EP3784201A1/fr
Application granted granted Critical
Publication of EP3784201B1 publication Critical patent/EP3784201B1/fr
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0003—Nasal or oral feeding-tubes, e.g. tube entering body through nose or mouth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00—Feeding-tubes for therapeutic purposes
    • A61J15/0026—Parts, details or accessories for feeding-tubes
    • A61J15/003—Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0046—Expandable retainers inside body lumens of the enteral tract, e.g. fixing by radially contacting a lumen wall
    • A61J15/0049—Inflatable Balloons

Definitions

  • the inflation device with its inflatable chamber may in particular be arranged in the proximity of the distal end of the tube by which a desired body cavity is accessed. Once the body cavity is accessed the inflatable chamber may be inflated to assume the second, inflated state such that the transnasal tube device is retained within the accessed body cavity and/or, for example, a reflux of liquid is prevented by the inflatable chamber blocking a fluid path for example through the esophagus.
  • the inflatable chamber In the second, inflated state the inflatable chamber is filled for example with air, wherein a rather low pressure may be sufficient for filling the inflatable chamber.
  • the volume of the inflatable chamber In the first, deflated state the volume of the inflatable chamber is reduced with respect to the volume of the inflatable chamber in the second, inflated state, hence allowing to pass the tube of the transnasal tube device in particular through the esophagus during placement of the transnasal tube device in the patient's body for accessing a body cavity of interest.
  • the tube of the transnasal tube device may in particular be a multi-lumen tube.
  • the tube may comprise a first lumen for administering a medical solution, such as a nutritional feeding solution, a medication or biotics, into a body cavity accessed by the transnasal tube device.
  • feeding equipment may for example be connected to the port of the tube at the first, proximal end of the tube, allowing feeding a medical solution to be delivered to the patient into the tube.
  • a second lumen in contrast, may be in fluid connection with the inflatable chamber of the inflation device, such that via the second lumen the inflatable chamber may be transferred from its first, deflated state to its second, inflated state and vice versa.
  • air may be guided to inflate the inflatable chamber to assume the second, inflated state.
  • the inflatable chamber preferably comprises a predefined shape formed by a suitable molding technique of a material having an increased hardness, a filling of the inflatable chamber at rather low pressure using air or even a partial filling may be sufficient.
  • a suction device may be connected to the second lumen of the tube at the first, proximal end of the tube, the suction device for example being constituted as a syringe which may be used to suck a predefined amount of air from the inflatable chamber such that the inflation device assumes the first, deflated state.
  • the suction device for example being constituted as a syringe which may be used to suck a predefined amount of air from the inflatable chamber such that the inflation device assumes the first, deflated state.
  • the suction device for transferring the inflatable chamber, after passing the tube towards the body cavity to be accessed, to the second, inflated state the amount of air previously sucked from the inflatable chamber using the suction device may be refilled into the inflatable chamber, having the advantage that the filling state of the inflatable chamber in the second, inflated state is exactly known.
  • Such suction device for example formed by a syringe, is cost-effective and may easily and intuitively be operated manually by a user.
  • a second inflatable chamber in between the first, proximal end and the second, distal end may be placed on the tube, the second inflatable chamber having similar characteristics to the inflatable chamber on the second, distal end of the tube, being made in particular from a material having a Shore-hardness greater than 64, preferably greater than 70, the material for example comprising polyurethane.
  • the second inflatable chamber may also be in fluid connection with the second lumen of the tube such that the inflatable chamber at the second, distal end and the second inflatable chamber in between the first, proximal end and the second, distal end of the tube may be inflated together via the second lumen.
  • the object is also achieved by a method for manufacturing a transnasal tube device for access to a body cavity of a patient through the esophagus, comprising:
  • the method is characterized by forming the inflatable chamber by a membrane envelope made of a material having a Shore-hardness equal to or greater than 64.
  • a transnasal tube device 1 comprises a tube 10 to be guided through the nose 23 and the esophagus 22 of the patient 2 towards a body cavity such as the patient's stomach 20 or the patient intestinal tract 21, in particular the patient's jejunum.
  • a medical solution such as a nutritional feeding solution for the enteral feeding of the patient 2
  • a medication or biotics may be fed directly into the body cavity 20, 21 accessed by the transnasal tube device 1, a suitable feeding device for this being connectable to a port 11 at a first, proximal end 100 of the tube 10 for feeding the medical solution into the tube 10 towards a second, distal end 101 of the tube 10 placed within the body cavity 20, 21 to be accessed.
  • the amount of air previously withdrawn from the inflatable chamber 150 is refilled into the inflatable chamber 150 by delivering the air from the suction device 16 into the inflatable chamber 150 (for example by pressing on a piston of the syringe forming a suction device 16), such that the chamber 150 is filled by a known amount of air at a known pressure.
  • the second lumen 14 at a first end 140 is in fluid connection with the connector 12 for connection to the suction device 16.
  • the second lumen 14 opens into the inflatable chamber 150 such that air may be passed through the second lumen 14 to/from the inflatable chamber 150.
  • the shape of the inflation device 15 with its membrane envelope 151 may be adapted to anatomic needs of the patient 2 and to a specific application, for example for placement of the tube 10 within the stomach 20 of the patient 2.
  • the membrane envelope 151 may be shaped, in particular when placing the tube 10 to access the patient's stomach 20, to prevent a reflux from the stomach 20 into the esophagus 22, which is to be avoided in particular when feeding a medical solution via the tube 10 into the stomach 20.
  • the inflation device 15 in the second, inflated state may be formed to block the entrance of the esophagus 22 at the stomach 20 such that fluid may not enter from the stomach 20 into the esophagus 22.
  • Fig. 2 and Fig. 3 are functionally identical, besides the different shape of the inflation device 15, the membrane envelope 151 in the second, inflated state having a spherical shape in the embodiment of Fig. 2 and a cylindrical shape in the embodiment of Fig. 3 .
  • the inflatable chamber 150 primarily serves to prevent a reflux through the esophagus 22 when placing the tube 10 of the transnasal tube device 1 within the patient's stomach 20.
  • the inflatable chamber 150 may assume, in the second inflated state, a substantially cylindrical shape which may adapt to the specific anatomy of the esophagus 22 such that the esophagus 22 is blocked and a reflux through the esophagus 22 is prevented, hindering an aspiration and a potential infection of the patient's lungs.
  • the inflatable chamber 150 may be fully filled or only partially filled for inflating the inflatable chamber 150. In each case a rather low pressure may be sufficient to fill the inflatable chamber 150, wherein a partial filling of the inflatable chamber 150 way furthermore be helpful to adapt the inflatable chamber 150 to the specific anatomy of for example the esophagus 22.
  • one or multiple inflatable chambers 150 can be placed at different locations on the tube 10, in particular close to the distal end 101, close to the proximal end 100 or in between the distal end 101 and the proximal end 100.
  • multiple chambers 150 of equal or different shape and of equal or different function may be provided on the tube 10 on different axial locations.
  • the inflatable chamber 150 comprises different portions 152, 153, a first portion 152 having a substantially spherical shape, whereas a second portion 153 has a substantially cylindrical shape.
  • the tube 10 comprises an inflatable chamber 150 having only one portion having a substantially spherical shape.
  • the inflatable chamber 150 assumes, in the second inflated state, a substantially cylindrical shape.
  • transnasal tube device of the type described herein may be used for different applications, for example for feeding a nutritional solution for the enteral feeding of a patient, for feeding a medication or for feeding biotics.
  • the tube may be a single lumen tube or a multi-lumen tube.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Otolaryngology (AREA)
  • Pulmonology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Claims (9)

  1. Dispositif de tube transnasal (1) permettant d'accéder à l'estomac (20) d'un patient (2) par l'œsophage (22), comprenant :
    - un tube (10) ayant une première, extrémité proximale (100) et une seconde, extrémité distale (101),
    - un orifice (11) agencé au niveau de la première, extrémité proximale (100) du tube (10) permettant d'introduire une solution médicale dans le tube (10), et
    - un dispositif de gonflage (15) agencé sur le tube (10), le dispositif de gonflage (15) comprenant une chambre gonflable (150) qui est conçue pour, dans un premier, état dégonflé, adopter un premier volume (V1) pour permettre un passage du tube (10) à travers l'œsophage (22) vers l'estomac (20) pour être accessible par le dispositif de tube transnasal (1) et, dans un second, état gonflé, adopter un second volume (V2) plus grand que le premier volume (V1), dans lequel la chambre gonflable (150), dans le second, état gonflé est formée pour retenir la sonde dans l'estomac (20) et pour prévenir le reflux,
    caractérisé en
    ce que la chambre gonflable (150) est définie par une enveloppe de membrane (151) faite d'un matériau ayant une dureté Shore A égale ou supérieure à 64, de préférence supérieure à 70, dans lequel l'enveloppe de membrane (151) adopte, dans le second, état gonflé, une forme prédéfinie constituée d'une technique de moulage et la chambre gonflable (150) comprend deux parties de chambre (152, 153), une première partie ayant une forme sensiblement sphérique et une seconde partie (153) ayant une forme sensiblement cylindrique.
  2. Dispositif de tube transnasal (1) selon la revendication 1, caractérisé en ce que le dispositif de gonflage (15) est agencé à proximité de l'extrémité distale (101) du tube (10).
  3. Dispositif de tube transnasal (1) selon la revendication 1 ou 2, caractérisé en ce que l'enveloppe de membrane (151) n'est sensiblement pas extensible au-delà du second, état gonflé de la chambre gonflable (150).
  4. Dispositif de tube transnasal (1) selon l'une quelconque des revendications 1 à 3, caractérisé en ce que l'enveloppe de membrane (151) est faite à partir d'un matériau comprenant du polyuréthane.
  5. Dispositif de tube transnasal (1) selon l'une quelconque des revendications précédentes, caractérisé en ce que le tube (10) comprend une première lumière (13) permettant d'administrer une solution médicale dans une cavité corporelle (20, 21) accessible par le dispositif de tube transnasal (1) et une seconde lumière (14) qui est en liaison fluidique avec la chambre gonflable (150) du dispositif de gonflage (15).
  6. Dispositif de tube transnasal (1) selon la revendication 5, caractérisé en ce que la chambre gonflable (150) du dispositif de gonflage (15) est gonflable en remplissant la chambre gonflable (150) avec de l'air à travers la seconde lumière (14).
  7. Dispositif de tube transnasal (1) selon la revendication 5 ou 6, caractérisé par un dispositif d'aspiration (16) pouvant être raccordé à la seconde lumière (14) au niveau de la première, extrémité proximale (100) du tube (10) permettant de transférer la chambre gonflable (150) entre le premier, état dégonflé et le second, état gonflé.
  8. Dispositif de tube transnasal (1) selon l'une quelconque des revendications précédentes, caractérisés en ce que la chambre gonflable (150), dans le second, état gonflé, est constitué pour empêcher un reflux à travers l'œsophage (22).
  9. Procédé de fabrication d'un dispositif tubulaire transnasal (1) permettant d'accéder à une cavité corporelle (20, 21) d'un patient (2) à travers l'œsophage (22), comprenant :
    - la fourniture d'un tube (10) ayant une première, extrémité proximale (100) et une seconde, extrémité distale (101),
    - l'agencement d'un port (11) au niveau de la première, extrémité proximale (100) du tube (10) permettant d'introduire une solution médicale dans le tube (10), et
    - le placement d'un dispositif de gonflage (15) sur le tube (10), le dispositif de gonflage (15) comprenant une chambre gonflable (150) qui est conçue pour, dans un premier, état dégonflé, adopter un premier volume (V1) pour permettre un passage du tube (10) à travers l'œsophage (22) vers une cavité corporelle (20, 21) pour être accessible par le dispositif de tube transnasal (1) et, dans un second, état gonflé, adopter un second volume (V2) plus grand que le premier volume (V1),
    caractérisé par
    la constitution de la chambre gonflable (150) par une enveloppe de membrane (151) faite d'un matériau dont la dureté Shore est égale ou supérieure à 64, de préférence supérieure à 70, dans lequel l'enveloppe de membrane (151) adopte, dans le second, état gonflé, une forme prédéfinie constituée d'une technique de moulage et la chambre gonflable (150) comprend deux parties de chambre (152, 153), une première partie ayant une forme sensiblement sphérique et une seconde partie (153) ayant une forme sensiblement cylindrique.
EP19716862.8A 2018-04-25 2019-04-04 Dispositif à tube transnasal pour accéder à une cavité corporelle d'un patient Active EP3784201B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP18169141 2018-04-25
PCT/EP2019/058496 WO2019206593A1 (fr) 2018-04-25 2019-04-04 Dispositif de tube transnasal pour l'accès à une cavité corporelle d'un patient

Publications (2)

Publication Number Publication Date
EP3784201A1 EP3784201A1 (fr) 2021-03-03
EP3784201B1 true EP3784201B1 (fr) 2025-08-13

Family

ID=62063358

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19716862.8A Active EP3784201B1 (fr) 2018-04-25 2019-04-04 Dispositif à tube transnasal pour accéder à une cavité corporelle d'un patient

Country Status (2)

Country Link
EP (1) EP3784201B1 (fr)
WO (1) WO2019206593A1 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4943275A (en) 1988-10-14 1990-07-24 Abiomed Limited Partnership Insertable balloon with curved support
DK0574378T3 (da) 1989-06-28 1996-03-11 David S Zimmon Ballon-tamponeringsanordning
EP0586717B1 (fr) * 1992-08-13 2001-12-12 Terumo Kabushiki Kaisha Tube endotrachéal et son procédé de fabrication
AU3098400A (en) 1998-11-09 2000-05-29 Datascope Investment Corp. Intra-aortic balloon catheter having an ultra-thin stretch blow molded balloon membrane
WO2008121603A1 (fr) * 2007-03-30 2008-10-09 Cook Critical Care Incorporated Tube d'alimentation pouvant être avancé automatiquement
US20150366760A1 (en) * 2014-05-30 2015-12-24 Ibrahim Elali Nasogastric tube anti aspiration device
US10456542B2 (en) * 2016-01-26 2019-10-29 Nicholas Richard Travis Insertable device to prevent aspiration of stomach contents during ventilation and intubation

Also Published As

Publication number Publication date
EP3784201A1 (fr) 2021-03-03
WO2019206593A1 (fr) 2019-10-31

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